Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
This study has been completed.
Procter and Gamble
Information provided by:
First received: September 12, 2005
Last updated: January 14, 2008
Last verified: January 2008
The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged >Ý 65 years with OAB.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.
Secondary Outcome Measures:
- Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.
- Safety and tolerability.
- Quality of life at week 6 and/or 12.
|Study Start Date:||April 2005|
|Study Completion Date:||June 2006|
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex
Placebo Comparator: 2
Placebo tablet once daily with sham titration
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171184
|United States, Texas|
|Scott Department of Urology Baylor College of Medicine|
|Houston, Texas, United States, 77030|
Sponsors and Collaborators
Procter and Gamble
|Study Chair:||Novartis||East Hanover NJ|